FDA Adverse Event
Malfunction
Summary report: N
ZIMMER NATURAL NAIL CEPHALOMEDULLARY GUIDE
MDR report key: 3142830
·
Received May 24, 2013
Report
- Report Number
- 1822565-2013-00871
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Report Date
- April 26, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT ON MULTIPLE OCCASIONS WHILE USING THE TARGETING GUIDES, THE SCREW WAS MISSING THE HOLE IN THE NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232705 | ZIMMER NATURAL NAIL CEPHALOMEDULLARY GUIDE | HSB | ZIMMER, INC. | 61595393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ZIMMER NATURUAL NAIL CEPHALOMEDULLARY GUIDE:| CAT #00249000300, LOT #61562144 |